Wednesday, May 23, 2012 12:51:23 PM
If you look at the table of second-line NSCLC control arms (see post# 80336) the range of the MOS values
goes from 5.7 to 8 months. Let's assume it is 5.8 months, within the range, but on the low side. When the
calculations were done that determined the MOS < 6 months it was about 7 months since the
last patient was enrolled in the trial. I think at that time if the MOS of the two treatment arms
was 7 months or less then it would be known and reported. So I think we can safely assume that at the current
time for the treatment arms MOS > 7 months, at least, and counting, maybe more like 8 months.
A 50% increase would mean MOS is about 8.7 months, assuming the 5.8 months for the control arm.
Another thing I would point out is that the two results for PFS from the two doses are fairly close together.
If you combine them the number of samples doubles and reduces the noise (variance) in the data.
So in the end it could be possible to combine the two arms as a "treatment" arm and that compared with
the control arm could be statistically significant even if each arm by itself is not.
That is, if the two doses result in PFS, or MOS, that are close together so there is a lot of overlap between
them and so statistically they can't be separated then the results could be combined and treated as one treatment arm.
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